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trials 12 articles

FDA’s latest Pradaxa advisory doesn’t mention the drug’s fatal flaw


In its most recent safety review of Pradaxa (dabigatrin), the U.S. Food and Drug Administration (FDA) says that the risk of serious bleeding associated with the new anticlotting drug appears to be no higher than the bleeding rates associated with warfarin (Coumadin), the decades-old anticoagulant drug Pradaxa was largely designed to replace. Although FDA regulators haven’t changed their recommendations for Pradaxa, they advised health care professionals prescribing the drug to carefully follow dosing recommendations on the drug’s label, especially when using it to treat patients with renal (kidney) impairment. However, the FDA fails to mention what is perhaps the drug’s ... Read More

Bleeding injuries prompt Pradaxa lawsuits in Tennessee


Charles Jackson, a retired 75-year-old truck driver from Hohenwald, Tennessee, started taking Boehringer Ingelheim’s blood-thinning drug Pradaxa after he had a stroke in September 2011. Mr. Jackson had been taking the drug for three weeks when he started to bleed intestinally, prompting his doctor to take him off the drug immediately. A similar thing happened to Roy Heady, 65, a retired electrician who lives near Cookeville, Tenn. Mr. Heady’s doctor switched him from Coumadin (warfarin) to Pradaxa as a stroke preventative. Shortly afterward, Mr. Heady was hospitalized for a hemorrhage and taken off the drug. “I thought it would lessen ... Read More

Pradaxa lawsuits consolidated for multidistrict litigation in Illinois

Lawsuits filed against the manufacturer of Pradaxa by patients and their families allegedly harmed by the new blood-thinning drug have been consolidated for Multidistrict Litigation (MDL) in U.S. District Court in the Southern District of Illinois. The Judicial Panel on Multidistrict Litigation moved unusually swiftly after hearing arguments for consolidation on July 26. On August 8, the panel decided the MDL cases would be litigated in under Judge David Herndon in East St. Louis, Illinois. According to one law firm that argued for consolidation, the judicial panel likely considered the advanced age and fragile health of the Pradaxa claimants when ... Read More

Takeda failed to warn about Actos bladder cancer risk, Lousiana plaintiff alleges

Actos remained on the market for more than a decade before consumers learned that prolonged use of the popular diabetes drug could elevate the risk of developing bladder cancer in patients. Now several former Actos users battling bladder cancer believe they could have made a better choice had Takeda Pharmaceutical Company warned patients of the drug’s apparent link to bladder cancer. One of the latest plaintiffs to file a lawsuit against Takeda and Eli Lily and Co., which partnered with the Japanese company to push the drug, is a Louisiana man who alleges Actos caused him to develop bladder cancer ... Read More

More adverse events tied to Pradaxa, warfarin than any other drugs in 2011, new report finds

If the number of adverse event reports the U.S. Food and Drug Administration receives is any indication, the blood thinner drug Pradaxa (dabigatran) could be one of the riskiest drugs on the market today. An analysis of FDA records conducted by the Institute for Safe Medicine Practices, QuarterWatch, found that Boehringer Ingelheim’s Pradaxa topped the list of direct reports of adverse events the FDA received in 2011. According to the analysis, the FDA received 817 direct reports of adverse events blamed on Pradaxa last year. Adding the number of reports received by the manufacturer brought the total number of serious ... Read More

Retired WWII vet files Pradaxa lawsuit in Connecticut


A lawsuit has been filed in Connecticut Superior Court against Boehringer Ingelheim Corp. on behalf of a Las Vegas man who allegedly suffered from “severe blood loss due to gastrointestinal bleeding,” while taking the blood thinner Pradaxa. The lawsuit is the first Pradaxa lawsuit to be filed against Boehringer Ingelheim in the state of Connecticut, the drug maker’s primary place of business. According to the lawsuit, the 86-year-old plaintiff, a World War II veteran and retired University of California administrator, started taking Pradaxa in January 2011. Less than two weeks later, he was rushed to the hospital with a severe ... Read More

Some DePuy ASR hip implant lawsuits heading to trial this year

The first lawsuits filed against health care giant Johnson & Johnson and its subsidiary DePuy Orthopaedics by plaintiffs alleging injuries caused by DePuy’s metal-on-metal ASR hip devices will go to court this year. About 4,200 lawsuits have been filed against the companies in federal court, with another 2,000 filed in state courts. The first state lawsuits are slated to go to trial in Las Vegas, Nevada, in mid-December 2012, with another trial scheduled for January 2012 in a Maryland state court. Federal lawsuits, which will be tried in U.S. District Court in West Virginia, will probably be heard in March ... Read More

Pradaxa linked to ‘serious harmful cardiovascular effects,’ study finds


A new study published by the Archives of Internal Medicine warns that patients taking the anticoagulant drug Pradaxa (dabigatran) face greater risks of heart attack and other harmful cardiovascular events than patients taking more conventional blood thinners. Pradaxa, which has been available in the United States since March 2008, came as a highly anticipated alternative to warfarin (Coumadin), a blood-thinning drug that has been around for nearly 60 years and is notoriously tricky to regulate within a patient’s body. The drugs are usually given to older patients with atrial fibrillation, an irregular heartbeat that decreases blood flow and increases the ... Read More

Actos linked to serious psychiatric impairments, medical reviewer alleges

The diabetes drug Actos is linked to higher rates of suicide, schizophrenia, epilepsy, and grand mal seizures compared to other drugs in the same class, such as Avandia, says Dr. Helen Ge, a former medical reviewer in Takeda Pharmaceuticals’ pharmacovigilance department. Dr. Ge has filed a whistleblower lawsuit against Takeda under the False Claims Act, alleging the company fired her for objecting to its practices of concealing, downplaying, and whitewashing data that linked Actos to serious adverse side effects. She alleges Takeda required her and other medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” Her ... Read More

Swedish doctor says Darvocet litigation may be bigger than Vioxx trials

The most surprising thing about Darvocet is probably that the now-banned painkiller, a combination of propoxyphene and acetaminophen, stayed on the market for decades even while consumer groups and health advocates warned about its serious health risks. When Darvocet first appeared on the market in the 1950s, it quickly became one the most-prescribed drugs in the United States, and when such a widely used drug is also one of the most dangerous drugs on the market, the extent of the damage done to public health is staggering. Swedish doctor Ulf Jonasson and his wife, Dr. Birgitta Jonasson, who have spent ... Read More